Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:

Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relationship between copper Cu 64-ATSM uptake and overall survival [ Time Frame: Three years ] [ Designated as safety issue: No ]

Relationship between copper Cu 64-ATSM uptake and rates of local recurrence and development of distant metastasis [ Time Frame: Three years ] [ Designated as safety issue: No ]

Relationship between copper Cu 64-ATSM uptake and frequency of complete metabolic response [ Time Frame: Three years ] [ Designated as safety issue: No ]

Accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease [ Time Frame: Three years ] [ Designated as safety issue: No ]

To define the role of pre-therapy ^64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis and determining the behavior of an invasive squamous cell cervical cancer in patients with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.

To determine whether higher copper Cu 64-ATSM uptake is associated with lower progression-free survival of these patients after chemoradiotherapy.

Secondary

To determine if higher copper Cu 64-ATSM uptake is associated with lower overall survival of these patients.

To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary cervical tumor recurrence and a higher rate of development of distant metastatic disease in these patients.

To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of complete metabolic response on FDG-PET/CT scan performed 3 months after completion of radiotherapy and chemotherapy.

To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease in these patients.

To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node metastasis at study entry.

No recurrent invasive carcinoma of the uterine cervix regardless of previous treatment

No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of the pelvis or abdominal lymph nodes at time of diagnosis

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

Able to lie flat for the duration of the PET/CT scan

No septicemia or severe infection

No uncontrolled or poorly controlled diabetes

No circumstances that would prevent completion of imaging studies or required clinical follow-up

No other prior or concurrent invasive malignancies, with the exception of non-melanoma skin cancer, within the past 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior pelvic or abdominal lymphadenectomy

No prior pelvic radiation therapy

No previous cancer treatment contraindicates this protocol therapy

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794339

Locations

United States, California

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, United States, 90089-9181

United States, Missouri

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

Saint Louis, Missouri, United States, 63110

Sponsors and Collaborators

American College of Radiology Imaging Network

Investigators

Principal Investigator:

Farrokh Dehdashti, MD

Mallinckrodt Institute of Radiology at Washington University Medical Center